Closure devices, systems, and methods

ABSTRACT

The present disclosure includes vessel closure devices, systems, and methods. A closure system configured to close a body lumen opening may include a handle member. A tube set configured to deliver and/or deploy a closure element may be coupled to the handle member. The closure system may also include an inner lumen with an anchor member at least partially disposed in the inner lumen. A plunger member may be movably coupled to the handle member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 12/684,400, filed Jan. 8, 2010, entitled “Closure Devices,Systems, and Methods,” which claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 61/143,751, entitled “VesselClosure Devices and Methods,” filed Jan. 9, 2009, the disclosure ofwhich is incorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

The present disclosure relates generally to medical devices and theirmethods of use. In particular, the present disclosure relates to vesselclosure systems and devices and corresponding methods of use.

2. The Technology

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guidewire may beadvanced through the needle and into the patient's blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guidewire into the vessel, e.g., in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guidewire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath wouldbe removed, leaving a puncture site in the vessel wall. Traditionally,external pressure would be applied to the puncture site until clottingand wound sealing occur; however, the patient must remain bedridden fora substantial period after clotting to ensure closure of the wound. Thisprocedure may also be time consuming and expensive, requiring as much asan hour of a physician's or nurse's time. It is also uncomfortable forthe patient and requires that the patient remain immobilized in theoperating room, catheter lab, or holding area. In addition, a risk ofhematoma exists from bleeding before hemostasis occurs. Although someclosure systems may be available, they provide limited control toflexibility to the operator, which may lead to improper or undesirableclosure of the puncture site.

BRIEF SUMMARY

The present disclosure can include a closure system. In one embodiment,the closure system can include a handle member, a tube set, an innerlumen disposed at least partially within the tube set, a plunger membermovably coupled to the handle member, and an anchor member at leastpartially disposed within the inner lumen. In a further embodiment, theanchor member can include an anchor portion and an elongate portion. Theanchor portion can be disposed in the inner lumen in an initialconfiguration and configured to move to an expanded configuration oncedeployed from the inner lumen.

The present disclosure can also include a method of closing a body lumenopening. In one embodiment, the method can include advancing a closuresystem at least partially into a body lumen opening. The closure systemcan include a handle member, a tube set configured to deliver and/ordeploy a closure element, an inner lumen disposed at least partiallywithin the tube set, a plunger member movably coupled to the handlemember, and an anchor member at least partially disposed within theinner lumen. In a further embodiment, the anchor member can include ananchor portion and an elongate portion, the anchor portion beingdisposed in the inner lumen in an initial configuration and configuredto move to an expanded configuration once deployed from the inner lumen.The method can also include deploying the anchor portion of the anchormember within the body lumen. In further embodiments, the method caninclude positioning the anchor portion of the anchor member against adistal surface of the lumen wall proximate the body lumen opening. Inyet further embodiments, the method can include advancing the tube setin a distal direction to position the distal end of the tube set againsta proximal surface of the lumen wall proximate the body lumen opening.In addition, the method can include deploying a closure element into thelumen wall proximate the body lumen opening to close the body lumenopening.

In a yet further embodiment, the present disclosure can include ananchor member. In one embodiment, the anchor member can include anelongate portion having a distal end and proximal end. In addition, theanchor member can include an anchor portion coupled to the distal end ofthe elongate portion. In a yet further embodiment, the anchor portion isconfigured to move elastically between an initial configuration and anexpanded configuration. The expanded configuration can include aplurality of projections.

These and other advantages and features of the present disclosure willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the disclosure as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify at least some of the advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the disclosure and aretherefore not to be considered limiting of its scope. The disclosurewill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 discloses a closure system in accordance with one exampleembodiment;

FIGS. 2A-2D disclose an example method of operating the closure systemof FIG. 1 in accordance with a further embodiment;

FIGS. 3A-3B disclose an example anchor member in accordance with a yetfurther embodiment;

FIGS. 4A-4B disclose an example anchor member in accordance with anadditional example embodiment;

FIGS. 5A-5D disclose an example method of operating the anchor member ofFIGS. 3A-3B in accordance with one embodiment;

FIGS. 6A-6G disclose an example method of closing a body lumen openingin accordance with a further embodiment;

FIGS. 7A-7G disclose the operation of an example tube set; and

FIG. 8 discloses an exploded view of an additional example closuresystem in accordance with a further embodiment.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of example configurations of the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure relates to devices, systems, and methods forclosing an opening in a body lumen. In one example embodiment, a closuresystem of the present disclosure may allow an operator to quickly andefficiently close a body lumen opening while simultaneously providingthe operator with a greater measure of control and flexibility inpositioning and anchoring the closure system than previously available.For example, the closure system may allow an operator to achieve a moreintimate securement of a closure element in the tissue surrounding abody lumen opening. In a yet further embodiment, the closure system maybe compatible with a wider range of body lumen wall thicknesses, therebytaking into account the possibility of calcifications or scar tissue inthe lumen wall. In addition, the closure system may be configured toadvance into a body lumen opening over a guidewire. Furthermore, theclosure system may be compatible with a variety of sizes of body lumenopenings and tissue tracts.

Embodiments of the disclosure further relate to a device closure systemwith a removable anchor. In one example, the anchor can be deployed froma contracted state to an expanded state. When in the expanded state, theanchor can be used to locate an opening in a vessel (e.g., anarteriotomy) when deploying, for example, a closure element, such as aclip or staple. The anchor, in conjunction with a tube set in theclosure system, may sandwich the tissue surrounding the opening in thevessel. This effectively locates the opening and aids in effective andproper deployment of the closure element.

The closure system may then retract or remove the anchor during use ofthe closure system, leaving the arteriotomy or opening at leastsubstantially closed or sealed by the closure element. During removal,the anchor can deform without dislodging the closure element. Morespecifically in one embodiment, the anchor is withdrawn back into thetube set and into the pre-deployed state. Thus, the closure system andclose an opening in a body lumen using a removable anchor.

Reference is now made to FIG. 1 which illustrates a closure system 100in accordance with an implementation of the present disclosure. Theclosure system 100 may be configured to close an opening in a bodylumen. The closure system 100 may include a handle member 110, a tubeset 120 coupled to the handle member 110, a plunger member 130, an innerlumen 140, and an anchor member 150 disposed at least partially withinthe inner lumen 140. An operator, such as a physician, may utilize theclosure system 100 and the elements thereof to close an opening in abody lumen. For example, as will be explained in more detail below, theplunger member 130 may be used to deploy the anchor member 150 to locatethe distal surface of a lumen wall and position the closure system 100relative to a body lumen opening. Thereafter, the handle member 110 andtube set 120 may be used to deliver a closure element, such as a clip orstaple, and deploy the closure element into the tissue of the body lumenwall to close or substantially close the body lumen opening.

The handle member 110 of the closure system 100 may be configured toassist an operator, such as a physician, to grip, manipulate, advance,and/or operate the closure system 100 in order to close a body lumenopening. In particular, the handle member 110 may have a shape and sizethat conforms to the shape and size of a human hand. The handle member110 may also include a number of indentations 112 configured to at leastpartially receive the fingers and/or thumbs of the operator. Theindentations 112 may assist the operator to grip and manipulate thehandle member 110 and closure system 100. The handle member 110 may alsoinclude one or more flanges 114 to assist an operator to grip, advance,and/or retract the handle member 110 and/or closure system 100.

The handle member 110 may also include any number of mechanismsnecessary to deploy a closure element. For example, the handle member110 may include a button 116 operatively associated with one or moremechanisms configured to deploy a closure element. The button 116 may bepositioned in or proximate to one of the one or more indentations 112.In a further embodiment, the button 116 may be operatively associatedwith one or more elements of the tube set 120 configured to deploy theclosure element 100. As a result, an operator may depress the button 116in order to push, fire, or eject a closure element from the tube set 120into the tissue of a body lumen to close a body lumen opening.

In a further embodiment, the handle member 110 may include a recess 118configured to receive at least a portion of the plunger member 130. Therecess 118 may be further configured to allow the plunger member 130 tomove in a longitudinal direction relative to the handle member 110. Inparticular, the recess 118 may allow the plunger member 130 to move bothdistally and proximally relative to the handle member 110. For example,the recess 118 may have a cross-sectional shape similar to, but slightlylarger than, the cross sectional shape of the plunger member 130. As aresult, the plunger member 130 may slide into and out of the recess 118to move relative to the handle member 110.

The handle member 110 may include any number of rigid or semi-rigidmaterials. For example, the handle member 110 may include any number ofpolymers, plastics, metals, composites, other similar materials, orcombinations thereof.

The tube set 120 may be coupled to and/or partially disposed within thehandle member 110. The tube set 120 may have a proximal end 122 coupledto the handle member 110 and opposite a distal end 124. The tube set 120may be configured to contain, deliver, and/or deploy a closure element.In particular, the tube set 120 may include one or more tubular membersand/or other mechanisms configured to house, advance, push, fire, and/oreject the closure element. For example, the tube set 120 may include apusher tube, a garage tube, a carrier tube, and/or other similarelements. In one embodiment, the tube set 120 may include aspring-loaded pusher member configured to deploy the closure elementwhen released or activated. Some example tube sets are disclosed inFIGS. 7-8 and described in more detail below.

The closure element may be disposed within the tube set 120 in aninitial, open configuration and may be configured to be deployed fromthe tube set 120 and move to a deployed, closed configuration. Inparticular, in one embodiment, the closure element may store sufficientenergy, while in its initial, open configuration, to engage the tissueof and close an opening in a lumen wall. For example, the closureelement may include any of a number of shape memory and/or superelasticmaterials and may be set to elastically return to a deployed, closedconfiguration from any other configuration. In one embodiment, theclosure element may include nitinol. In a further embodiment, theclosure element may be a clip, staple, or other closure element.

The closure system 100 may also include an inner lumen 140. The innerlumen 140 may be disposed at least partially within the tube set 120,the handle member 110, and/or the plunger member 130. In a furtherimplementation, the inner lumen 140 may be movable, such as slidable,with respect to the tube set 120, the handle member 110, and/or theplunger member 130. As a result, the inner lumen 140 may move eitherdistally or proximally relative to the tube set 120, the handle member110, and/or the plunger member 130.

The inner lumen 140 may be configured to house and deliver the anchormember 150 to or away from a body lumen opening. In a furtherembodiment, the inner lumen 140 may be integrated into or replaced by anelement of the tube set 120. The inner lumen 140 may include any numberof flexible or semi-rigid materials. For example, the inner lumen mayinclude one or more polymers, elastomers, plastics, metals, composites,other similar materials, or combinations thereof.

As introduced above, the closure system 100 may include an anchor member150. The anchor member 150 may be configured to locate, position theclosure system 100 relative to, and/or anchor the tissue surrounding abody lumen opening. The anchor member 150 may include an anchor portion152 and an elongate portion 154. The anchor portion 152 may beconfigured to be positioned and/or anchored against the distal surfaceof a lumen wall. The elongate portion 154 may be coupled to the anchorportion 152 and may be configured to control, deploy, position,stabilize, and/or retract the anchor portion 152. In particular, theelongate portion 154 may extend away from the anchor portion 152 in aproximal direction through the inner lumen 140, the tube set 120, thehandle member 110, and/or the plunger member 130. In a furtherembodiment, the elongate portion 154 may be coupled at its proximal end122 to the plunger member 130. In a yet further embodiment, the elongateportion 154 may be selectively detachable from and recouplable to theplunger member 130.

The anchor portion 152 of the anchor member 150 may be disposed in aninitial, contracted configuration within the inner lumen 140. Theelongate portion 154 of the anchor member 150 may extend proximally fromthe anchor portion 152 to the plunger member 130. In addition, theelongate portion 154 may transfer forces from the plunger member 130 tothe anchor portion 152. Accordingly, by advancing the plunger member 130or elongate portion 154 in a distal direction relative to the innerlumen 140 an operator may deploy the anchor portion 152 of the anchormember 150 from the distal end of the inner lumen 140. Retracting theplunger member 130 in a proximal direction may position and/or anchorthe anchor portion 152 against a distal surface of a lumen wall. In afurther embodiment, further retracting the plunger member 130 in aproximal direction may retract the anchor portion 152 of the anchormember 150 from the body lumen and/or into the inner lumen 140 or tubeset 120.

The anchor portion 152 of the anchor member 150 may be configured tomove from an initial, contracted configuration within the inner lumen140 to a deployed, expanded configuration once deployed from the innerlumen 140. To facilitate movement from an initial, contractedconfiguration to a deployed, expanded configuration, the anchor portion152 of the anchor member 150 may include one or more superelastic orshape memory materials such as shape memory alloys. For example, and aswill be explained in more detail below, the anchor portion 152 be heatset in a deployed, expanded configuration. The anchor portion 152 maythen be elastically deformed into an initial, contracted configurationcontracted and disposed within the inner lumen 140. In its initial,contracted configuration, the anchor portion 152 may store sufficientenergy to return to its deployed, expanded configuration once releasedfrom the inner lumen 140.

In one embodiment, a user may operate the plunger member 130 to deployand/or retract the anchor member 150. For example, the plunger member130 may be configured to at least partially receive the tube set 120and/or the inner lumen 140. In a further embodiment, the plunger member130 may also be configured to receive a portion of the anchor member 150and/or a guidewire. In a further embodiment, the inner lumen 140 and/oranchor member 150 may be coated to minimize friction within the innerlumen 140 to ease deployment.

The proximal end 122 of the plunger member 130 may be configured to begripped and/or operated by an operator such as a physician. For example,an operator may grip the handle member 110 with a first hand and gripthe proximal end of the plunger member 130 with a second hand in orderto advance or retract the plunger member 130 relative to the handlemember 110. As a result, the operator may deploy the anchor portion 152of the anchor member 150 from the inner lumen 140 and/or position theanchor portion 152 against a distal surface of a lumen wall therebylocating the body lumen opening to be closed.

Thereafter, the operator may advance the handle member 110 in a distaldirection relative to the plunger member 130 and inner lumen 140 toposition the distal end 124 of the tube set 120 against a proximalsurface of the lumen wall. By so doing, the operator may facilitate theclosure of the body lumen opening by at least partially gripping,sandwiching, and/or immobilizing the tissue surrounding the body lumenopening. The operator may then deploy a closure element into the tissueof the lumen wall to close the body lumen opening.

The shape of the plunger member 130 may correspond with the shape of therecess 118 to facilitate relative movement between the handle member 110and the plunger member 130. For example, the cross sectional shape ofboth the plunger member 130 and the recess 118 may be any shape desiredsuch as circular, triangular, rectangular, or other shapes, orcombinations thereof. In addition, the length of the plunger member 130and the corresponding depth of the recess 118 may be any length anddepth desired to allow sufficient relative movement between the plungermember 130 and handle member 110. For example, the length of the plungermember 130 and the corresponding depth of the recess 118 may besufficient to allow deployment of the anchor portion 152 from the innerlumen.

In a further embodiment, the closure system 100 may include aself-tensioning mechanism configured to automatically provide tension inthe anchor member 150 once the anchor portion 152 has deployed. Forexample, in one embodiment, the handle member 110 may include a springmechanism disposed in the recess 118 and configured to resist and/orcounteract movement of the plunger member 130 in a distal directionrelative to the handle member 110. In particular, advancing the plungermember 130 in a distal direction relative to the handle member 110 maytransfer energy to the spring mechanism, which may be released once theoperator releases the plunger member 130.

As a result, the spring mechanism may move the plunger member 130 in aproximal direction relative to the handle member 110 thereby retractingthe anchor portion 152 in a proximal direction, thereby automaticallyengaging the distal surface of a lumen wall, and/or advancing the handlemember 110 and tube set 120 in a distal direction, thereby engaging theproximal surface of the lumen wall. The spring mechanism can also createsufficient tension within the anchor member 150 to produce a desiredpressure on the tissue of the lumen wall between the anchor portion 152and the tube set 120. Accordingly, the closure system 100 mayautomatically and efficiently create the desired sandwiching orimmobilizing force on the tissue surrounding the body lumen opening. Inaddition, the spring mechanism may make it unnecessary for the operatorto provide the movement or force necessary to position the closuresystem 100 relative to the body lumen opening. In additionalembodiments, any other self-tensioning mechanism may be included in theclosure system 100 to produce to desired tension in the anchor member150 and force upon the tissue surrounding the body lumen opening. In ayet further embodiment, the plunger member 130 and closure system 100may have a click or ratchet function similar to that of a “click” pen.

In a yet further embodiment, the closure system 100, or the elementsthereof, may include a mechanism for determining the thickness of alumen wall and/or the distance between the anchor portion 152 and thedistal end 124 of the tube set 120. For example, the plunger member 130may have a plurality of indicator lines along the length thereof. Theindicator lines may be positioned and marked to indicate the position ofthe deployed anchor portion 152 relative to the distal end 124 of thetube set 120. In particular, the number of indicator lines exposed asthe plunger member 130 is retracted may indicate the thickness of thetissue surrounding the body lumen opening being closed. The indicatorlines may be calibrated so that they read zero thickness when the anchorportion 152 is position directly against the distal end 124 of the tubeset 120. As a result, the operator may refer to the indicator lines todetermine the position of the anchor portion 152 relative to the distalend 124 of the tube set 120 and/or the thickness of the tissuesurrounding a body lumen opening.

Additionally, the closure system 100 may incorporate at least onecomponent of the closure systems 600 and 800, tube sets 720 and 820, andanchor members 350, 450, 550, and 650 described in connection with FIGS.3-6, respectively.

Reference is now made to FIGS. 2A-2D, which illustrate an example methodof operating the closure system 100 of FIG. 1. In particular, FIG. 2Aillustrates the closure system 100 in an initial configuration. In thisinitial configuration, the plunger member 130 may be fully retractedrelative to the handle member 110, and the anchor portion 152 of theanchor member 150 may be disposed within the inner lumen 140. Advancingthe plunger member 130 in a distal direction relative to the handlemember 110, the tube set 120, and the inner lumen 140 may deploy theanchor portion 152 of the anchor member 150 from the inner lumen 140, asshown in FIG. 2B. As a result, the anchor portion 152 may move from aninitial, contracted configuration to a deployed, expanded configuration.In a further implementation, the plunger member 130 may include two ormore plunger components. For example, the plunger member 130 may includea first component configured to deploy and/or retract the anchor member150 and a second component configured to advance and/or retract theinner lumen 140. In a yet further implementation, the first and secondcomponents of the plunger member 130 may be movable with respect to oneanother.

Thereafter, retracting the plunger member 130 in a proximal directionrelative to the handle member 110, the tube set 120, and/or the innerlumen 140 may retract the anchor portion 152 in a proximal direction, asshown in FIG. 2C. As shown in FIG. 2D, advancing the handle member 110in a distal direction relative to the plunger member 130 may advance thetube set 120 in a distal direction until the distal end 124 of the tubeset 120 is proximate the anchor portion 152 of the anchor member 150. Asa result, an operator of the closure system 100 may locate, anchor,and/or immobilize the tissue surrounding a body lumen opening betweenthe tube set 120 and anchor portion 152. Thereafter, the operator maydeploy a closure element into the body lumen surrounding the body lumenopening to close the body lumen opening.

Reference is now made to FIGS. 3A-3B, which disclose an example anchormember 350 in accordance with implementations of the present disclosure.The example anchor member 350 of this configuration may be functionallysimilar to the example anchor member 150 previously described above andshown in FIGS. 1-2 in most respects, wherein certain features will notbe described in relation to this configuration wherein those componentsmay function in the manner as described above and are herebyincorporated into this additional configuration described below. Likestructures and/or components are given like reference numerals.Additionally, the anchor member 350 may incorporate at least onecomponent of the anchor members 450, 550, and 650 described inconnection with FIGS. 4-6, respectively.

The anchor member 350 may be configured to assist an operator to locate,anchor, immobilize, and/or support a body lumen opening and/or thesurrounding tissue of the lumen wall. The anchor member 350 may includean anchor portion 352 and an elongate portion 354. The anchor portion352 may include any size and/or shape configured to anchor against asurface of a lumen wall or to locate a body lumen opening. For example,the anchor portion may include a plurality of projections 356 configuredto engage the tissue of a lumen wall. The projections 356 may be shaped,positioned, and/or oriented in any configuration desired to providepositioning or anchoring support. The anchor portion 352 may include anynumber of projections 356 desired. In the embodiment shown in FIGS.3A-3B the anchor portion 352 of the anchor member 350 includes fourprojections 356, however, the anchor portion 352 may have fewer or moreprojections 356 than four.

In one embodiment, the projections may extend in a direction or a planesubstantially perpendicular to the longitudinal axis of the elongateportion 354. In one configuration, the projections 356 may be rounded.In particular, the projections 356 may be leaf-shaped or pedal-shaped.In a further embodiment, the anchor portion 352 may have a shapesubstantially similar to a four leaf clover.

The anchor portion 352 may be coupled to the distal end of the elongateportion 354. The elongate portion 354 may include one or more elongatemembers 358. The elongate member(s) 358 may be configured to advance,retract, position, and/or deploy the anchor portion 352. In particular,the elongate member(s) 358 may be longitudinally rigid or semi-rigid tofacilitate advancing or retracting the anchor portion 352. In oneembodiment, the elongate member(s) 358 may have a solid configurationsuch as a nitinol wire or a mandrel. In further embodiments, theelongate member(s) 358 may have a generally tubular configuration.

The anchor portion 352 and/or elongate portion 354 may include anynumber of materials. In one embodiment, the anchor portion 352 mayinclude the same materials as the elongate portion 354. In a furtherembodiment, the anchor portion 352 may include different materials thanthe elongate portion 354.

In one embodiment, the anchor portion 352 and elongate portion 354 mayinclude a single shape memory or superelastic wire forming both theelongate portion 354 and the anchor portion 352. The wire may be setinto any shape desired for the elongate portion 354 and anchor portion352. In particular, the wire may be set in an elongate form for theelongate portion 354 and may be set with a plurality of bights or bedsforming the expanded form of the anchor portion 352. As shown in FIGS.3A-3B, in one configuration, the wire may form a plurality ofprojections 356.

The anchor portion 352 may be configured to elastically deform to anyshape and then return to its expanded shape illustrated FIGS. 3A-3B oncereleased. For example, the anchor portion 352 may be elasticallydeformed into an elongate and/or contracted configuration and disposedwithin a lumen. While in this contracted configuration, the anchorportion 352 may store sufficient energy to return to its expandedconfiguration. Once the anchor portion 352 is deployed from the lumen,the anchor portion 352 may release the stored energy and return to itsexpanded configuration.

In a further embodiment, the anchor portion 352 of the anchor member 350may include one or more gripping elements along a proximal surface. Thegripping elements may be configured to provide a frictional orimmobilizing force on tissue surrounding a body lumen opening. Forexample, the anchor portion 352 may include a plurality of ridges orteeth along a proximal surface configured to engage and grip orimmobilize the tissue surrounding a body lumen opening.

Reference is now made to FIGS. 4A-4B, which illustrate an additionalanchor member 450 in accordance with a further embodiment of the presentdisclosure. The example anchor member 450 of this configuration may befunctionally similar to the example anchor members 150 and 350previously described above and shown in FIGS. 1-3 in most respects,wherein certain features will not be described in relation to thisconfiguration wherein those components may function in the manner asdescribed above and are hereby incorporated into this additionalconfiguration described below. Like structures and/or components aregiven like reference numerals. Additionally, the anchor member 450 mayincorporate at least one component of the anchor members 550 and 650described in connection with FIGS. 5-6, respectively.

In one embodiment, the anchor member 450 may include an anchor portion452 and an elongate portion 454. The anchor portion 452 may include aplurality of projections 456 extending substantially perpendicular tothe longitudinal axis of the elongate portion 454. As shown, the anchorportion 452 may include a figure-8 shape having two projections 456.However, the anchor portion 452 may be configured to have any desiredshape and/or size having any number of projections.

The elongate portion 454 may include one or more elongate members 458.In one embodiment, the elongate member(s) 458 and anchor portion 452 maybe part of a single continuous piece of shape memory or superelasticwire. For example, the wire may extend along the elongate portion 454and may form the projections 456 of the anchor portion 452 and then mayterminate or alternatively extend again along the elongate portion 454.In a further embodiment, portions of the wire may overlap itself orcross over in forming the anchor portion 452. The overlaps or crosses ofthe wire may provide better resistance against collapse or more supportto the anchor portion 452.

Reference is now made to FIGS. 5A-5D, which illustrate a method ofdeploying and retracting an anchor member 550. The example anchor member550 of this configuration may be functionally similar to the exampleanchor members 150, 350, and 450 previously described above and shown inFIGS. 1-4 in most respects, wherein certain features will not bedescribed in relation to this configuration wherein those components mayfunction in the manner as described above and are hereby incorporatedinto this additional configuration described below. Like structuresand/or components are given like reference numerals. Additionally, theanchor member 550 may incorporate at least one component of the anchormember 650 described in connection with FIGS. 6A-6G.

In particular, FIG. 5A illustrates the anchor member 550 disposed withina lumen 540 in an initial, contracted configuration. As shown, theanchor member 550 may include an elongate portion 554 and an anchorportion 552. The elongate portion 554 may include a plurality ofelongate members 558, such as a first elongate member 558A and a secondelongate member 558B.

As shown in FIG. 5B advancing the elongate portion 554, such as one orboth of the elongate members 558, in a distal direction relative to thelumen 540 may deploy the anchor portion 552 from the distal end of thelumen 540. As a result, the anchor portion 552 may move from an initial,contracted configuration to a deployed, expanded configuration. In oneembodiment, the deployed, expanded configuration may include a pluralityof projections 556. In a further embodiment, retracting the elongateportion 554 in a proximal direction may provide an anchoring force. Forexample, retracting the elongate members 558 may anchor the anchorportion 552 against the distal surface of a lumen wall or any othersurface against which the anchor portion 552 is positioned, as shown inFIG. 5C. In one embodiment, retracting both elongate members 558simultaneously may produce tension or some other force in the anchorportion 552 which may increase the resistance of the anchor portion 552to contracting. For example, the tension of both elongate members 558may be simultaneously transferred to the anchor portion 552 therebycreating sufficient tension in the anchor portion 552 to resist movementby the anchor portion 552 away from its expanded configuration. Inaddition, providing an opposing force against a proximal surface of theanchor portion 552, such as with the lumen wall, may also assist increating sufficient tension in the anchor portion 552 to resistcontraction of the anchor portion 552. In a further implementation, thewires of the anchor portion 552 may overlap or cross over each other inorder to increase resistance.

As shown in FIG. 5D, retracting only one elongate member, such as thefirst elongate member 558A, may lessen the tension in the anchor portion552, thereby allowing the anchor portion to move from its deployed,expanded configuration to a contracted configuration. As a result, byretracting only the first elongate member 558A, without applying tensionto the second elongate member 558B or with applying a distal force tothe second elongate member 558B, the anchor portion 552 may contract andbe retracted into the lumen 540. In further implementations, byretracting only the second elongate member 558B, without applyingtension to the first elongate member 558A or with applying a distalforce to the first elongate member 558A, the anchor portion 552 maycontract and/or be retracted into the lumen 540.

Reference is now made to FIGS. 6A-6G, which illustrate a method ofclosing a body lumen opening using a closure system 600. The exampleanchor member 650 of this configuration may be functionally similar tothe example anchor members 150, 350, 450, and 550 previously describedabove and shown in FIGS. 1-5 in most respects, wherein certain featureswill not be described in relation to this configuration wherein thosecomponents may function in the manner as described above and are herebyincorporated into this additional configuration described below. Likestructures and/or components are given like reference numerals. Inaddition, the closure system may incorporate at least one element of thetube set 720 of FIGS. 7A-7G or closure system 800 of FIG. 8.

As shown in FIG. 6A, the closure system 600 may be at least partiallyadvanced into a body lumen opening. For example, after completing apercutaneous medical procedure, an operator may advance the closuresystem 600 over a guidewire 660 through a tissue tract 680 and through abody lumen opening 675 in a lumen wall 670. In particular, the operatormay advance the closure system 600 until the inner lumen 640 of theclosure system 600 extends at least partially into the body lumen 690.Once the closure system 600 has been advanced at least partially intothe body lumen 690 the operator may then retract the guidewire 660 fromthe body lumen 690.

As shown in FIG. 6B, once the closure system 600 is advanced into thebody lumen 690, the operator may deploy the anchor member 650 into thebody lumen 690. As explained in more detail above, the operator maydeploy the anchor member 650 by advancing the plunger member 630 and/orelongate portion 654 in a distal direction relative to the handle member610, the tube set 620, and the inner lumen 640. Once deployed from theinner lumen, the anchor portion 652 of the anchor member 650 may movefrom an initial, contracted configuration to a deployed, expandedconfiguration. As shown in FIG. 6C, once the anchor portion 652 of theanchor member 650 has been deployed within the body lumen 690, theoperator may retract the plunger member 630 and/or closure system 600 toposition the anchor portion 652 of the anchor member 650 against thedistal surface of the lumen wall 670 proximate the body lumen opening asalso shown in FIG. 6C′. In particular, the operator may retract theplunger member 630 and/or closure system 600 until she feels theanchoring force or resistance from the anchor portion 652 of the anchormember 650 against the distal surface of the lumen wall 670 therebylocating the body lumen opening 675 and anchoring or securing the tissuesurrounding the body lumen opening 675. As shown, the anchor portion 652may include a plurality of projections 656 which engage and anchor thetissue of the lumen wall 670. In particular, the projections 656 mayextend in a direction substantially perpendicular to the longitudinalaxis of the elongate portion 654, the tube set 620, and/or inner lumen640.

Once the anchor portion 652 has located the body lumen opening 675and/or anchored or secured the tissue surrounding the body lumen opening675, the operator may advance the handle member 610 in a distaldirection relative to the plunger member 630 in order to advance thetube set 620 in a distal direction relative to the anchor portion 652.In particular, the operator may advance the handle member 610 and/ortube set 620 until the distal end 624 of the tube set 620 engages theproximal surface of the lumen wall 670 proximate or surrounding thelumen opening. As a result, in one embodiment, by advancing the tube set620 in a distal direction and/or retracting the anchor portion 652 in aproximal direction, the operator may sandwich the tissue of the lumenwall 670 surrounding the body lumen opening 675 between the tube set 620and the anchor portion 652. Accordingly, the operator may thereby engageand/or at least partially immobilize the tissue surrounding the bodylumen opening 675. This may facilitate the successful deployment of aclosure element 695 into the tissue surrounding the body lumen opening675, thereby, facilitating the closure of the body lumen opening 675. Inparticular, the tube set 620 and the anchor portion 652 may hold thetissue in place while a closure element is deployed into the tissue.Therefore, as shown in FIG. 6E the operator may then deploy a closureelement 695 into the tissue surrounding the body lumen opening. In oneembodiment, the operator may depress the button 616 to eject or deploythe closure element 695 into the lumen wall 670. In particular, theclosure element 695 may be deployed from an initial, open configurationto a deployed, closed configuration, thereby, engaging and bringing thetissue surrounding the body lumen opening 675 together to close the bodylumen opening 675. The closure element 695 may include any deviceconfigured to close a body lumen opening 675. For example, the closureelement 695 may include a staple, a clip, other similar devices, orcombinations thereof.

As shown in FIG. 6F, once the closure element 695 has been deployed, thehandle member 610, tube set 620, and/or inner lumen 640 may be retractedout of and/or away from the body lumen 690 and tissue tract 680, asshown in FIG. 6F. Thereafter, the anchor member 650 may be retracted byretracting the elongate portion 654 in a proximal direction. Forexample, in one embodiment the anchor portion 652 may be pulled throughthe closure element 695. The closure element 695 may have superelasticproperties to facilitate the withdrawal of the anchor portion 652through the closure element 695. For example, the closure element may atleast partially expand to facilitate the withdrawal of the anchorportion 652 and then return to a contracted position to close the bodylumen opening 675. Accordingly, by following one or more of the actsdisclosed in FIGS. 6A-6G, an operator may efficiently close a body lumenopening 675 with a greater amount of flexibility and control.

In one embodiment, the inner lumen 640 can be held in place against theouter surface of the body lumen while the anchor member 650 isretracted. Holding the inner lumen 640 may provide sufficient force toallow the anchor member and more particularly the anchor portion 652 todeform into the pre-deployment state inside of the inner lumen 640. Aspreviously stated, this may be achieved by retracting a single elongatemember. This may ensure that the closure element does not becomedislodged as the anchor portion 652 is withdrawn and contracted. Infurther embodiments, the anchor wire may be substantially smaller thanthe closure element. As a result, pulling the anchor portion 652 throughthe closure element may not affect the positioning of the closureelement since the closure element anchors in the tissue by design. Inone implementation, the wire of the anchor portion 652 may besuperelastic with a diameter small enough to not require substantialforce to collapse the anchor portion 652 and pull it through thedeployed closure element. For example, the anchor wire may have adiameter of around 0.005-.007″.

In one configuration, the anchor, closure element, and/or other aspectsor components of the closure system disclosed herein can be made of asingle material or of multiple materials. This can include a metalprimary material and polymer/drug topcoat or a different metal toplayer. The multiple layers can be resiliently flexible materials orrigid and inflexible materials, and selected combinations thereof. Theuse of resiliently flexible materials can provide force-absorbingcharacteristics, which can also be beneficial for absorbing stress andstrains, which may inhibit crack formation at high stress zones. Also,the multiple layers can be useful for applying radiopaque materials. Forexample, types of materials that are used to make a closure element canbe selected so that the closure element is capable of being in a firstorientation (e.g., delivery orientation) during placement and capable oftransforming to a second orientation (e.g., deploying orientation) whendeployed to close the opening in a lumen.

Embodiments of the anchor, closure element and the like can include amaterial made from any of a variety of known suitable biocompatiblematerials, such as a biocompatible shape memory material (SMM). Forexample, the SMM can be shaped in a manner that allows for a deliveryorientation while within the tube set, but can automatically retain thememory shape of the closure element once deployed into the tissue toclose the opening. SMMs have a shape memory effect in which they can bemade to remember a particular shape. Once a shape has been remembered,the SMM may be bent out of shape or deformed and then returned to itsoriginal shape by unloading from strain or heating. Typically, SMMs canbe shape memory alloys (SMA) comprised of metal alloys, or shape memoryplastics (SMP) comprised of polymers. The materials can also be referredto as being superelastic.

Usually, an SMA can have an initial shape that can then be configuredinto a memory shape by heating the SMA and conforming the SMA into thedesired memory shape. After the SMA is cooled, the desired memory shapecan be retained. This allows for the SMA to be bent, straightened,twisted, compacted, and placed into various contortions by theapplication of requisite forces; however, after the forces are released,the SMA can be capable of returning to the memory shape. The main typesof SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel;nickel-titanium (NiTi) alloys known as nitinol; nickel-titaniumplatinum; nickel-titanium palladium; and cobalt-chromium-nickel alloysor cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and can be tuned by varying the elementalratios or by the conditions of manufacture. This can be used to tune theclosure element so that it reverts to the memory shape to close thearteriotomy when deployed at body temperature and when being releasedfrom the tube set.

For example, the primary material of a closure element can be of a NiTialloy that forms superelastic nitinol. In the present case, nitinolmaterials can be trained to remember a certain shape, retained withinthe tube set, and then deployed from the tube set so that the tinespenetrate the tissue as it returns to its trained shape and closes theopening. Also, additional materials can be added to the nitinoldepending on the desired characteristic. The alloy may be utilizedhaving linear elastic properties or non-linear elastic properties.

An SMP is a shape-shifting plastic that can be fashioned into a closureelement in accordance with the present disclosure. Also, it can bebeneficial to include at least one layer of an SMA and at least onelayer of an SMP to form a multilayered body; however, any appropriatecombination of materials can be used to form a multilayered device. Whenan SMP encounters a temperature above the lowest melting point of theindividual polymers, the blend makes a transition to a rubbery state.The elastic modulus can change more than two orders of magnitude acrossthe transition temperature (Ttr). As such, an SMP can be formed into adesired shape of an endoprosthesis by heating it above the Ttr, fixingthe SMP into the new shape, and cooling the material below Ttr. The SMPcan then be arranged into a temporary shape by force and then resume thememory shape once the force has been released. Examples of SMPs include,but are not limited to, biodegradable polymers, such asoligo(ε-caprolactone)diol, oligo(ρ-dioxanone)diol, and non-biodegradablepolymers such as, polynorborene, polyisoprene, styrene butadiene,polyurethane-based materials, vinyl acetate-polyester-based compounds,and others yet to be determined. As such, any SMP can be used inaccordance with the present disclosure.

An anchor, closure element and the like may have at least one layer madeof an SMM or suitable superelastic material and other suitable layerscan be compressed or restrained in its delivery configuration within thegarage tube or inner lumen, and then deployed into the tissue so that ittransforms to the trained shape. For example, a closure elementtransitions to close the opening in the body lumen while an anchor mayexpand to anchor the closure system.

Also, the anchor, closure element, or other aspects or components of theclosure system can be comprised of a variety of known suitabledeformable materials, including stainless steel, silver, platinum,tantalum, palladium, nickel, titanium, nitinol, nitinol having tertiarymaterials (U.S. 2005/0038500, which is incorporated herein by reference,in its entirety), niobium-tantalum alloy optionally doped with atertiary material (U.S. 2004/0158309, 2007/0276488, and 2008/0312740,which are each incorporated herein by reference, in their entireties)cobalt-chromium alloys, or other known biocompatible materials. Suchbiocompatible materials can include a suitable biocompatible polymer inaddition to or in place of a suitable metal. The polymeric closureelement can include biodegradable or bioabsorbable materials, which canbe either plastically deformable or capable of being set in the deployedconfiguration.

In one embodiment, the closure element or anchor may be made from asuperelastic alloy such as nickel-titanium or nitinol, and includes aternary element selected from the group of chemical elements consistingof iridium, platinum, gold, rhenium, tungsten, palladium, rhodium,tantalum, silver, ruthenium, or hafnium. The added ternary elementimproves the radiopacity of the nitinol closure element. The nitinolclosure element has improved radiopacity yet retains its superelasticand shape memory behavior and further maintains a thin body thicknessfor high flexibility.

In one embodiment, the anchor or closure element can be made at least inpart of a high strength, low modulus metal alloy comprising Niobium,Tantalum, and at least one element selected from the group consisting ofZirconium, Tungsten, and Molybdenum.

In further embodiments, the closure element or anchor can be made fromor be coated with a biocompatible polymer. Examples of suchbiocompatible polymeric materials can include hydrophilic polymer,hydrophobic polymer biodegradable polymers, bioabsorbable polymers, andmonomers thereof. Examples of such polymers can include nylons,poly(alpha-hydroxy esters), polylactic acids, polylactides,poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide,polyglycolic acids, polyglycolide, polylactic-co-glycolic acids,polyglycolide-co-lactide, polyglycolide-co-DL-lactide,polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides,polyesters, polyorthoesters, polycaprolactones, polyesters,polyanydrides, polyphosphazenes, polyester amides, polyester urethanes,polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols,polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcoholcopolymers, ethylenevinylalcohol copolymers (EVAL),propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP),combinations thereof, polymers having monomers thereof, or the like.

Reference is now made to FIGS. 7A-7G, which disclose an example tube set720. The example tube set 720 of this configuration may be functionallysimilar to the example tube set 120 and 620 previously described aboveand shown in FIGS. 1, 2, and 6 in most respects, wherein certainfeatures will not be described in relation to this configuration whereinthose components may function in the manner as described above and arehereby incorporated into this additional configuration described below.Like structures and/or components are given like reference numerals.Additionally, the tube set 720 may incorporate at least one component ofthe tube set 820 of FIG. 8. In further embodiments, the tube set 720 maybe utilized with the closure systems 100 and 600 disclosed in FIGS. 1,2, and 6.

The tube set 720 may include a garage sheath 722, a pusher tube 724, anda carrier tube 726. In addition, the tube set 720 may be configured toreceive or house a locator element and closure element 795. In oneembodiment, the tube set 720 may house an inner lumen 740, and/or anchormember 750. In further embodiments, the tube set 720 may be configuredto deliver and/or deploy the closure element 795 in order to close anopening in a lumen wall.

The garage sheath 722 may be configured to cover, protect, and/or housethe closure element 795 within the tube set 720 and/or other componentsof the tube set 720. In one embodiment, the garage sheath 722 may begenerally tubular in shape. In a further embodiment, the distal end ofthe garage sheath 722 may have a different configuration than theremainder of the garage sheath 722. For example, the distal end of thegarage sheath 722 may have an inwardly tapered configuration. In furtherembodiments, the distal end may be configured to at least partiallyexpand to facilitate deployment of the closure element 795. For example,the distal end of the garage sheath 722 may include one or morelongitudinal slits thereby forming one or more flanges that may deflectradially outwardly in order to facilitate deployment of the closureelement 795.

In addition to the garage sheath 722, the tube set 720 may include apusher tube 724. The pusher tube 724 may be configured to deploy theclosure element 795. In one embodiment, the pusher tube 724 may begenerally tubular in shape along the length thereof. The pusher tube 724may be disposed between the carrier tube 726 and the garage sheath 722and proximal of the closure element 795. In a further embodiment, thedistal end of the pusher tube 724 may include one or more fingers orprojections extending from the distal end of the pusher tube 724 andconfigured to help stabilize and/or deploy the closure element 795. Forexample, the fingers or projections extending from the distal end of thepusher tube 724 may be configured in size to fit into correspondingwaves, undulations, or other features along a proximal edge or surfaceof the closure element 795.

In addition to the pusher tube 724, the tube set 720 may include acarrier tube 726. The carrier tube 726 may be configured to carry theclosure element 795 in a delivery configuration to a location proximatean opening in a body lumen. In one embodiment, the carrier tube 726 maybe generally tubular in shape along the length thereof. The carrier tube726 may be disposed at least partially within the pusher tube 724 withthe closure element 795 disposed thereon. In further embodiments, thedistal end of the carrier tube 726 may have a different configurationthan the remainder of the carrier tube 726. For example, the distal endof the carrier tube 726 may flare radially outwards to facilitatesuccessful deployment of the closure element 795. For example, theflared distal end of the carrier tube 726 may direct one or moreelements of the closure element 795 outwards to engage tissuesurrounding the opening in the body lumen to better close the body lumenopening.

The garage sheath 722, pusher tube 724, and/or carrier tube 726 mayinclude any of a number of materials, such as biocompatible polymersand/or metals. In one example, one or more of the garage sheath 722,pusher tube 724, and/or carrier tube 726 may include stainless steel.The materials of the garage sheath 722, pusher tube 724, and/or carriertube 726 may have rigid, semi-rigid, or flexible mechanical propertiesas desired for a particular embodiment.

The garage sheath 722, pusher tube 724, and/or carrier tube 726 may belongitudinally movable relative to each other. The independentlongitudinal movement of each element of the tube set 720 may facilitatethe deployment of the closure element 795 and corresponding closure of abody lumen opening. As shown in FIG. 7A, the tube set 720 may have aninitial delivery configuration, in which the closure element 795 isdisposed on the corner tube 726 and the anchor member 750 is disposedwithin the carrier tube 726. In this initial delivery configuration, amedical care provider or user can move the tube set 720 into positionwithin or near an opening in a body lumen.

Once the tube set 720 is in position proximate a body lumen opening, theuser of the tube set 720 can advance the inner lumen 740 at leastpartially into the body lumen, as shown in FIG. 7B. Once the inner lumen740 is partially disposed within the body lumen, the user may advancethe anchor portion 752 of the anchor 750 by advancing the elongatemember(s) 754 relative to the inner lumen 740 and tube set 720. As aresult, the anchor portion 752 may deploy from a delivery configurationto a deployed configuration as described in more detail above.

Once the anchor portion 752 is deployed within the body lumen, the usermay retract the anchor 750 in a proximal direction to position theanchor portion 752 against the distal surface of the body lumensurrounding the opening, as shown in FIG. 7C. In a further embodiment,the user can retract the garage tube 722 in order to expose the closureelement 795, as shown in FIG. 7D.

Once the carrier tube 726 is anchored against the body lumen, the usercan deploy the closure element 795 by advancing the pusher tube 724 in adistal direction relative to the carrier tube 726, as shown in FIG. 7E.As the pusher tube 724 advances, it may come into contact with theclosure element 795 and begin to advance the closure element 795 in adistal direction relative to the carrier tube 726. In furtherembodiments, as the closure element 795 advances, the flared distal endof the carrier tube 726 may expand the closure element 795 and directone or more tines of the closure element 795 radially outward to betterengage the tissue surrounding the opening in the body lumen.

As shown in FIG. 7F, the user can continue to advance the pusher tube724 until the closure element 795 extends at least partially beyond thedistal end of the carrier tube 726 and into engagement with the bodylumen. Once deployed beyond the carrier tube 726, the closure element795 may move from its expanded, delivery configuration to a deployed,collapsed configuration, thereby closing the body lumen opening, asshown in FIG. 7G. In addition, the user can retract the anchor portion752 through the deployed closure element 795, as disclosed in moredetail above. In further embodiments, the user may retract the tube set720 and anchor 750 in a proximal direction away from the body lumen andout of the tissue tract, thereby leaving the deployed closure element inplace.

Reference is now made to FIG. 8, which illustrates an additional exampleclosure system 800 in accordance with a further embodiment of thepresent disclosure. The example closure system 800 of this configurationmay be functionally similar to the example closure systems 100 and 600and tube set 720 previously described above and shown in FIGS. 1, 2, 6,and 7 in most respects, wherein certain features will not be describedin relation to this configuration wherein those components may functionin the manner as described above and are hereby incorporated into thisadditional configuration described below. Like structures and/orcomponents are given like reference numerals. Additionally, the closuresystems 100 and 600 and tube set 720 may incorporate one or morecomponents of the closure system 800.

As shown, the closure system 800 may include a handle member 810, a tubeset 820 configured to couple with or be partially disposed within thehandle member 810, and a plunger member 830 and firing pin 816configured for manipulation by a user in order to operate the closuresystem 800 and deploy a closure element, such as a clip or staple. As aresult, a user, such as a physician, may utilize the closure system 800and the elements thereof to close an opening in a body lumen.

The handle member 810 of the closure system 800 may be configured toassist an operator, such as a physician, to grip, manipulate, advance,and/or operate the closure system 800 in order to close a body lumenopening. In one embodiment, the handle member may have an upper portion810 a and a lower portion 810 b. The upper portion 810 a and lowerportion 810 b may be connected using one or more fasteners, adhesives,welds, and/or other mechanisms. In further embodiments, the handlemember may define a recess 818 configured to house one or morecomponents of the closure system 800. The recess 818 may be configuredto receive components of the tube set 820 as well as other components ofthe closure system 800 disclosed in FIG. 8 and described in more detailbelow. In yet further embodiments, the recess 818 may have openingsalong the sides thereof configured to receive portions of the tube set820 during operation of the closure system 800.

As shown, the closure element 800 may also include a tube set 820. Inone embodiment, the tube set 820 may include a garage tube 822, pushertube 824, and carrier tube 826. In further embodiments, each of thegarage tube 822, pusher tube 824, and carrier tube 826 may include aslider block at its proximal end configured to be disposed within andslide along the recess 818 of the handle member 810. Each of the sliderblocks may be further configured to lock within the openings along thesides of the recess 818 to restrict or control the movement of eachmember of the tube set 820. For example, after moving in a distaldirection to position the components of the tube set 820 for deploymentof a closure element, one or more of the slider blocks may lock into theopenings to restrict further movement, such as in a proximal direction.

The handle member 810 may also be operatively associated with any numberof mechanisms configured to deploy a closure element. For example, thehandle member 810 may include a button 816 operatively associated withone or more mechanisms configured to deploy a closure element. Thebutton 816 may be operatively associated with a firing pin 817configured to release stored energy to fire or deploy a closure element.For example, the closure system 800 may store energy in a spring 815. Inone embodiment, the spring 815 may be disposed on and/or betweencomponents of the tube set 820. In further embodiments, the energy maybe transferred to the spring 815 by depressing the plunger member 830. Auser may release the stored energy by depressing the button 816, whichmay release the firing pin 817. In one embodiment, the stored energy maytransfer to the pusher tube 824 in order to deploy the closure element.As a result, an operator may depress the button 816 in order to push,fire, or eject a closure element from the tube set 820 into the tissueof a body lumen to close a body lumen opening.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1.-26. (canceled)
 27. An anchor member configured to locate and/oranchor tissue surrounding a body lumen opening comprising: an elongateportion configured to be manipulated by a user and slidably receivedwithin a longitudinal lumen of a tubular member, the elongate portionhaving at least a first elongate member; and an anchor portion havingone or more contracted configurations when positioned in thelongitudinal lumen of the tubular member, the one or more contractedconfigurations capable of passing through a body lumen opening, and theanchor portion having one or more expanded configurations capable ofanchoring tissue surrounding a body lumen opening, wherein the anchorportion is movable between the one or more contracted configurations andthe one or more expanded configurations by moving the first elongatemember longitudinally relative to the tubular member.
 28. The anchormember of claim 27, wherein the anchor member includes a shape-memorymaterial.
 29. The anchor member of claim 28, wherein the anchor memberincludes a shape memory wire forming both the elongate portion and theanchor portion.
 30. The anchor member of claim 27, wherein the one ormore contracted configurations are substantially perpendicular to theone or more expanded configurations.
 31. The anchor member of claim 27,wherein the one or more expanded configurations include at least onerounded projection.
 32. The anchor member of claim 31, wherein the atleast one rounded projection is connected to a straight portion of theanchor portion.
 33. The anchor member of claim 32, wherein the at leastone rounded projection turns at least 180 degrees before the straightportion.
 34. The anchor member of claim 27, wherein the anchor portionhas a first end and a second end, the first end being connected to theelongate portion and the anchor portion terminating at the second end.35. The anchor member of claim 27, wherein the elongate member has atubular configuration.
 36. The anchor member of claim 35, wherein theanchor member has a first end and a second end, the first end and secondend being connected to the elongate portion.
 37. An anchor memberconfigured to locate and/or anchor tissue surrounding a body lumenopening comprising: an elongate portion configured to be manipulated bya user and slidably received within a longitudinal lumen of a tubularmember, the elongate portion having at least a first elongate member,the elongate portion having a longitudinal axis; and an anchor portionhaving a contracted configuration capable of passing through a bodylumen opening and having an expanded configuration capable of anchoringtissue surrounding a body lumen opening, wherein the expandedconfiguration has a plurality of projections including at least a firstprojection and a second projection extending radially outward relativeto the longitudinal axis, the first projection having a first radiallyoutwardmost point and the second projection having a second radiallyoutwardmost point, the first radially outwardmost point and secondradially outwardmost point radially opposing one another.
 38. The anchormember of claim 37, wherein the first radially outwardmost point has afirst radius relative to the longitudinal axis and the second radiallyoutwardmost point has a second radius relative the longitudinal axis,the first radius and second radius being the same.
 39. The anchor memberof claim 37, wherein the plurality of projections are oriented at equalrotational intervals about the longitudinal axis.
 40. The anchor memberof claim 37, wherein at least a portion of a projection of the pluralityof projections longitudinally overlaps a portion of another projectionof the plurality of projections in the expanded configuration.
 41. Theanchor member of claim 37, wherein at least a portion of a projection ofthe plurality of projections longitudinally overlaps a portion ofanother projection of the plurality of projections in the contractedconfiguration.
 42. A method of closing an opening in a body lumen, themethod comprising: positioning at least part of closure system throughan opening in a bodily lumen; deploying an anchor member of the closuresystem in a bodily lumen, the anchor member having a longitudinal axis,an elongate portion, and an anchor portion, the elongate portion beingsubstantially parallel to the longitudinal axis, applying force in adistal direction to an elongate member of the elongate portion to movethe anchor portion from a contracted configuration to an expandedconfiguration; applying force in a proximal direction to move the anchorportion proximally and against the bodily lumen; and retracting theelongate member of the elongate portion and maintaining at least part ofthe anchor member stationary to collapse the anchor member from theexpanded configuration to the contracted configuration.
 43. The methodof claim 42, wherein applying force in a distal direction to theelongate member includes maintaining at least part of the anchor memberstationary longitudinally and moving at least part of the anchor memberradially relative to the longitudinal axis.
 44. The method of claim 43,wherein moving at least part of the anchor member radially relative tothe longitudinal axis includes expanding a plurality of roundedprojections.
 45. The method of claim 44, wherein applying force in aproximal direction to move the anchor portion proximally and against thebodily lumen comprises contacting the bodily lumen with the plurality ofrounded projections.
 46. The method of claim 44, wherein the pluralityof rounded projections extend perpendicularly to the longitudinal axis.